Recruiting

Virtual Reality vs. Standard-of-Care

Sponsor:

University of British Columbia

Code:

NCT03681717

Conditions

Laceration

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Interventions

Virtual Reality

Study Details

Brief summary:

Lacerations are a common reason for presentation to the Emergency Department and children needing laceration repair with sutures are experiencing pain and anxiety.

Virtual Reality (VR) is an immersive experience using sight, sound, and position sense. Using VR may enhance distraction during the painful procedure and may reduce attention to pain.

This study will randomize children (6 - 16 years old) to receive Virtual Reality or standard of care in addition to pharmacoanalgesia during a laceration repair procedure. Investigators will measure pain, anxiety, satisfaction, amount of analgesia and the length of procedure and compare between the two groups.

Conditions

Laceration

Study ID

NCT03681717

Start date

Feb 1, 2018

Status verified date

Sep, 2018

Completion date

Jan 31, 2019

Anticipated

Primary completion date

Jan 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 16

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children age 6 - <17 years
  • Arriving to the Emergency Department with a chief complaint of laceration
  • The managing physician determines need for repair with suture
  • Parents will sign a consent form and children will sign an assent form

Exclusion Criteria:

  • Children with conditions that may prohibit participation or evaluation of the procedure (such as developmental delay)
  • Triage category 1 (resuscitation)
  • Facial features or injury prohibiting wearing VR goggles

Study Design

Enrollment

64 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Virtual Reality

Participants are distracted by wearing the virtual reality headset and watching a roller coaster app during laceration repair with sutures.

no intervention: Control (Standard-of-Care)

Participants are distracted with Standard-of-Care by doctors, nurses, nurse practitioners, child life specialists and/or parents.

Interventions

Virtual Reality

Participants wear a Virtual Reality headset that consists of a ASUS phone and a ReTrack Utopia 360 VR Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.

Primary outcome measure

  • Pain using the Faces Pain Scale - Revised. [ Time Frame: Pain is reported by children immediately following completion of the laceration repair ]

Central Contacts and Locations

Central contacts

Ran D. Goldman, MD

604-875-2345rgoldman@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Ran D. Goldman, MD

604-875-2345rgoldman@cw.bc.ca

Principal Investigator:

Amir Behboudi, MD

More Information

Sponsor

University of British Columbia

Last update posted

Sep 24, 2018

Last verified

Sep, 2018

Keywords

  • Virtual Reality
  • Pain
  • Anxiety

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2018-09-24.